Effects of clarithromycin on inflammatory markers and clinical manifestations in postsurgical follow-up of patients with endometriosis: a double-blinded randomized placebo-controlled clinical trial

Abstract

Purpose

Studies showed anti-inflammatory and immunomodulatory effects of macrolide antibiotics such as clarithromycin in endometriosis. Therefore, the present study aims to investigate the therapeutic efficacy of clarithromycin in patients with endometriosis.

Methods

This was a double-blinded randomized placebo-controlled trial conducted on endometriotic women during March 2016–2017 in Dena Hospital, Shiraz, Iran. Immediately after surgery, the patients were randomly divided into clarithromycin (real) (n = 120) and placebo group (n = 169). The real group received 500 mg of clarithromycin everyday for 6 months and the placebo group received the placebo. The serum levels of tumor necrosis factor-alpha (TNF-α), interleukin-10 (IL-10), Erythrocyte sedimentation rate (ESR) and C-reactive protein as well as clinical symptoms at baseline and 3 and 6 months of post-surgery were compared within and between groups.

Results

The scores of dysmenorrhea, dyschezia, dyspareunia, and non-menstrual pain significantly decreased in both real and placebo groups compared with the baseline values. However, the real group showed greater reductions compared with the placebo group (p < 0.001). Similarly, the serum levels of CRP, TNF-α, and IL-10 decreased in both groups compared with the baseline values, but the real group showed greater reductions. Interestingly, the reductions in the clinical symptoms and serum levels did not significantly differ between the real and placebo groups. Moreover, the reductions in the studied variables showed no dependence on the time.

Conclusion

Clarithromycin may be an appropriate treatment in endometriotic patients. However, the non-significant differences between the real and placebo groups necessitate further studies on the therapeutic efficacy of clarithromycin.

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Funding

This study was financially supported by Shiraz University of Medical Sciences, Shirza, Iran (Grant No.: 91-01-01-4809).

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Affiliations

Authors

Contributions

SA: project administration, methodology. TP: conceptualization, validation, writing—review and editing. EA: software, validation, writing—original draft. GD: data curation, formal analysis.

Corresponding author

Correspondence to Tahereh Poordast.

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Conflict of interest

All authors declare that they have no conflict of interest on publishing this study.

Ethical approval

All of the protocols and experimental procedures of this study were approved by the local Ethics Committee of Shiraz University of Medical Sciences, Shiraz, Iran (Code: IR.sums.rec.1394.S744) which were in complete accordance with the ethical regulations of human studies set by the Helsinki Declaration (2014).

Informed consent

Informed consent was obtained from all the patients who participated in this study.

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Cite this article

Alborzi, S., Poordast, T., Askary, E. et al. Effects of clarithromycin on inflammatory markers and clinical manifestations in postsurgical follow-up of patients with endometriosis: a double-blinded randomized placebo-controlled clinical trial. Arch Gynecol Obstet 299, 1305–1312 (2019). https://doi.org/10.1007/s00404-019-05057-4

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Keywords

  • Endometriosis
  • Clarithromycin
  • Tumor necrosis factor-alpha
  • Interleukin-10
  • Dysmenorrhea
  • Dyspareunia
  • Dyschezia